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FDA device classification & product code lookup

Find a medical device's three-letter FDA product code, its device class (1, 2 or 3), the 21 CFR regulation that classifies it, and the premarket submission type. Search by product code (for example FRN), device name, or regulation number (for example 880.5725).

Reference only. Data from FDA's public openFDA classification data; it may lag FDA's own database. The class and regulation describe the device type, not a specific model or its clearance. openFDA says: “Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.”

What the fields mean

From FDA's description of its product code file:

  • Product code: “3 character unique product identifier”.
  • Device class: “Class 1 - Devices subject to General Controls”, “Class 2 - Devices subject to General Controls and Special Controls”, “Class 3 - Devices subject to General Controls, Special Controls, and Premarket Clearance”.
  • Regulation number: “If the database does not reference a regulation number, the device has not yet been classified and the device class listed (1, 2, or 3) is proposed, not final.”
  • Submission type: 510(K), PMA, Contact ODE, 510(K) Exempt, HDE - Humanitarian Device Exemption, Enforcement Discretion, or EUA - Emergency Use Authorization.
  • Device name: “The Device Name uses the format of a noun that is usually followed by one or more adjectives, separated by commas.” That's why an infusion pump is listed as “Pump, Infusion”.

How it works

Your search goes to our server, which asks openFDA's device classification endpoint for up to 25 matching product codes. Each result links to FDA's recall records for that product code in our recall quick-check. Answers are cached for up to 24 hours so we stay inside openFDA's public rate limits; each result shows openFDA's own “last updated” date. We don't store what you search.

Sources

Data provided by the U.S. Food and Drug Administration (https://open.fda.gov). This tool is not endorsed by FDA. Last verified 2026-10-18. Reference aid, not legal, regulatory or clinical advice.

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